Sr. Manager, Investigations

Job Overview 

The Sr. Manager, Investigations provides strategic and operational leadership for investigation activities related to quality events, compliance issues, and regulatory requirements impacting DePuy Synthes products and operations. This role is accountable for ensuring investigations are thorough, timely, compliant, and consistently executed across the organization. The position partners closely with Quality, Regulatory Affairs, Manufacturing, R&D, Legal, and Compliance to identify root causes, define corrective and preventive actions, and reduce risk to patients, customers, and the business. This is a highly visible role with direct impact on product quality, regulatory compliance, and continuous improvement. 

Key Responsibilities 

• Lead and oversee investigation activities related to quality events, nonconformances, complaints, deviations, and compliance issues. 

• Ensure investigations are conducted in accordance with internal procedures, regulatory requirements, and global quality system standards. 

• Drive consistent root cause analysis and corrective and preventive action (CAPA) development and effectiveness. 

• Partner cross‑functionally with Manufacturing, Quality, Regulatory Affairs, R&D, and Legal to assess risk and resolve complex issues. 

• Establish and maintain investigation governance, metrics, and reporting to monitor performance, trends, and compliance. 

• Support regulatory inspections, audits, and health authority interactions by providing investigation expertise and documentation. 

• Identify systemic issues and lead continuous improvement initiatives to reduce recurrence and improve investigation quality. 

• Lead, coach, and develop investigation teams or subject‑matter experts, fostering accountability and high performance. 

• Embed Johnson & Johnson’s Credo and Leadership Imperatives into decision‑making, people leadership, and issue resolution. 

Qualifications 

Education 

• Bachelor’s degree required, preferably in Engineering, Life Sciences, Quality, or a related technical field. 

• Advanced degree (Master’s or PhD) preferred. 

Experience and Skills 

Required 

• Typically requires 8–10 years of progressive experience in investigations, quality, compliance, or related roles within a regulated industry. 

• Demonstrated expertise in investigation methodologies, root cause analysis, and CAPA processes. 

• Strong knowledge of medical device regulations and quality system requirements (e.g., FDA, ISO). 

• Proven people‑leadership experience, including coaching, performance management, and team development. 

• Ability to lead complex issue resolution and influence senior stakeholders in a matrixed environment. 

Preferred 

• Experience supporting regulatory inspections, audits, or health authority inquiries. 

• Background in orthopedic or implantable medical device manufacturing. 

• Experience using electronic quality management systems (eQMS). 

• Experience leading global or multi‑site investigation teams. 

• Training or certification in root cause analysis or quality methodologies (e.g., Six Sigma). 

• Strong analytical, communication, and decision‑making skills. 

Other 

• Language: English proficiency required. 

• Travel: Up to 15–20% domestic and/or international travel. 

• Certifications (preferred): ASQ, Six Sigma, or equivalent quality certifications.